CytoDyn Inc (OTCMKTS:CYDY) a biotech company focused on the formulation of new therapies for fighting human immunodeficiency virus infection, confirmed that it finalized an agreement with the U.S. FDA on its previously submitted Phase III protocol synopsis for drug candidate PRO 140, a novel antibody for the cure of HIV. The company submitted the full Phase III protocol to the U.S. FDA, which provides for a 25-week trial with 300 HIV enrollments. The study could start thirty days after submission.
The expectations
CytoDyn believes that after successful conclusion of the Phase III trial, the company can seek accelerated approval for its drug candidate PRO 140. It can also apply for a breakthrough status for PRO 140 being the first ‘self-injectable’ antibody to treat HIV therapy.
The data
CytoDyn recently concluded Phase II b treatment substitution study showed that 98% of all patients administered with PRO 140 effectively passed four weeks of monotherapy, and there was no virologic failure. The company then offered 14 patients an alternative to become a part of extension study, and all of them successfully passed trial period of six months of monotherapy without suffering from virologic failure.
The plans
CytoDyn Inc (OTCMKTS:CYDY) first Phase III trial study is planned to enable PRO 140 as a part of a HAART regimen for experienced patients. It is the existing standard of medical care for patients suffering with HIV. The management expects the market for a HAART therapy could surpass a billion dollars. CytoDyn team is confident that PRO 140 has compelling benefits over Maraviroc. These include fewer side-effects, less toxicity, and once-a-week administration. The FDA agrees with company’s proposed regulatory path.
In last trading session, the stock price of CytoDyn surged more than 4% to close the trading session at $0.900. The gains came at a share volume of 277,543 compared to average share volume of 61,313.
